Simultaneous HPLC Analysis of Olmesartan and Hydrochlorothiazide in Combined Tablets and in vitro Dissolution Studies

Sağırlı, Olcay; Önal, Armağan; Toker, Sıdıka Ertürk; Şensoy, Demet

doi:10.1365/s10337-007-0304-9

Cited by 46 publications

(28 citation statements)

References 23 publications

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“…OLM is also reported to be effective in animal models of atherosclerosis, liver disorders, and diabetic nephropathy. 3 This drug, practically insoluble in water and slightly soluble in methanol, is considered a weak basic compound (pKa = 4.3), and is chemically known as 5-methyl-(2-oxo-1,3-dioxol-4-yl) methyl-4-(1-hydroxy-1-methylethyl)-2-propyl-1-[2´(1H)-tetrazol5yl)1,1´biphenyl(-4-yl)methyl]-1H-imidazole-5-carboxylate]. 4 An official technique for OLM quantification in solid dosage forms has not yet been described in the literature.…”

Section: Introductionmentioning

confidence: 99%

“…4 An official technique for OLM quantification in solid dosage forms has not yet been described in the literature. However, methods for determination of this drug isolated in biological fluids (plasma and urine), such as LC coupled with fluorescence and tandem mass spectrometry, 2,[5][6][7] or combined with other drugs 8,9 have been reported. Different methods using LC for determination of this antihypertensive to indicate OLM stability have been reported, [10][11][12][13] but CE (Capillary Electrophoresis) has not been previously used for this purpose.…”

Section: Introductionmentioning

confidence: 99%

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Stability-indicating comparative methods using mekc and lc for determination of olmesartan medoxomil

et al. 2013

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Recebido em 24/2/12; aceito em 25/7/12; publicado na web em 11/12/12 A stability-indicating method using MEKC was validated for the analysis of olmesartan medoxomil in tablets. Successful separation was achieved using a fused silica capillary (40 cm x 50 μm i.d.); background electrolyte consisted of a combination of 10 mmol L -1 borate buffer and 5 mmol L -1 anionic detergent sodium dodecyl sulfate (95:5; v/v) pH 6.5; hydrodynamic mode at 50 mBar for 5 s; 25 kV separation voltage at 25 °C; and column temperature 25 °C with detection at 257 nm. The proposed method, validated following ICH guidelines, was applied to the determination of this antihypertensive with good results compared with an LC method.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Stability-indicating comparative methods using mekc and lc for determination of olmesartan medoxomil

et al. 2013

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“…Due to the fact that hydrolysis of Olmesartan in human plasma is extremely rapid [3]. The drug works by inhibiting the effects of angiotensin II, a potent vasoconstrictor and one of the key contributors to cardiovascular and renal disease [4]. The presence of impurities also called as related substances in an active pharmaceutical (API) can have a significant impact on the quality and safety of the drug products.…”

Section: Introductionmentioning

confidence: 99%

Development and Validation of Stability Indicating LC Method for Olmesartan Medoxomil

Kameswara¹,

Kishore²,

Maddala³

et al. 2012

AJAC

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The present method provides the detailed description of development and validation of a simple stability indicating reverse phase column liquid chromatographic method for Olmesartan in the presence of its impurities namely Imp-A, Imp-B, Imp-C, Imp-D, Imp-E, Imp-F and Imp-G and degradation products generated from forced degradation studies. The drug substance was subjected to stress conditions of aqueous hydrolysis, Oxidative, photolytic and thermal stress degradation. The degradation of Olmesartan was observed under acid hydrolysis, base hydrolysis and peroxide. The drug was found to be stable to other stress conditions attempted. Successful separation of the drug from synthetic impurities and degradation products formed under stress conditions was achieved on symmetry C18, 150 mm × 4.6 mm, 5 μ column using a phosphate buffer, Acetonitrile and Milli Q water. The developed LC method was validated with respect to specificity, linearity, accuracy, precision, raggedness and robustness. The assay method was found to be linear in the range of 250 μg·mL -1 to with 1000 μg·mL -1 correlation coefficient of 0.9999 and the linearity of the impurities was established from LOQ to 0.4%. Recoveries of assay and impurities were found between 98.5% and 101.2%. The developed LC method to determine the related substances and assay determinations of Olmesartan can be used to evaluate the quality of regular production samples and stability samples. To best of our knowledge, the validated stability indicating LC method which separates all the impurities disclosed in this investigation was not published elsewhere.

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“…Celebier et al presented an UV-VIS spectrophotometry and Capillary Zone Electrophoresis methods for the determination of olmesartan medoxomil in tablets [7][8] . A validated absorption factor spectrophotometric and HPLC methods for analysis of olmesartan medoxomil in combined pharmaceutical formulations were published 9,10 . In the present study, a rapid, simple, accurate and reproducible validated chromatographic isocratic RP-HPLC and HPTLC analytical methods were developed for the quantitative estimation of olmesartan medoxomil in drug substance and in drug product without the interference of tablet excipients and its degradates.…”

Section: Introductionmentioning

confidence: 99%

Acid- Alkali Degradation Study on Olmesartan Medoxomil and Development of Validated Stability-Indicating Chromatographic Methods

Moussa

Mohamed

Youssef

2010

J. Chil. Chem. Soc.

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A reversed phase liquid chromatography (RP-HPLC) and thin layer chromatography (HPTLC) densitometry methods as a stability indicating assays of olmesartan medoxomil in presence of its acid or alkaline induced degradation products were developed. Olmesartan medoxomil and its degradation products were analyzed by HPLC equipped with UV-Variable wave length detector at 257 nm where quantitation was achieved by isocratic elution on Agilent, Exclipse XDB-C 18 column with mobile phase composed of acetonitrile: methanol: water: glacial acetic acid (40:35:25:0.1 v/v/v/v) at flow rate 1ml min.-1 . HPTLC was performed on aluminum packed Nano silica gel 60 F 254 TLC plates as stationary phase with significant difference in Rƒ values between olmesartan medoxomil and its degradates using chloroform: methanol: formic acid (8:1.5:0.5 v/v/v) as mobile phase. Densitometric evaluation of intact drug was carried out at 260 nm. The calibration curve of olmesartan medoxomil in bulk form was linear from 0.5-10 µg ml -1 and 0.05-1 mg ml -1 with mean percentage accuracy 99.97 ± 1.085 % and 100.35 ± 1.060 % for HPLC and HPTLC methods, respectively. The two proposed methods were successfully applied for the determination of olmesartan medoxomil in drug substance and in drug product. Methods validation was tested for linearity; accuracy; precision; selectivity and robustness, according to USP guidelines.

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Simultaneous HPLC Analysis of Olmesartan and Hydrochlorothiazide in Combined Tablets and in vitro Dissolution Studies

Cited by 46 publications

References 23 publications

Stability-indicating comparative methods using mekc and lc for determination of olmesartan medoxomil

Stability-indicating comparative methods using mekc and lc for determination of olmesartan medoxomil

Development and Validation of Stability Indicating LC Method for Olmesartan Medoxomil

Acid- Alkali Degradation Study on Olmesartan Medoxomil and Development of Validated Stability-Indicating Chromatographic Methods

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